CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides mixed with Montanide ISA 51 Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Biological: CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1

CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides mixed with Montanide ISA 51 Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Detailed Description:

CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 have been identified as cancer specific molecules especially in breast cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these molecules and identified that these peptides significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of these peptides. Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be administered until patients develop progressive disease or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the safety and tolerability of these peptides vaccine. Also we evaluate the immunological and clinical response of this vaccine therapy.

Eligibility

Ages Eligible for Study:

20 Years to 85 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Advanced or recurrent breast cancer

Resistant against anthracycline-based and taxane-based chemotherapy or difficult to continue the chemotherapy due to intolerable side effect(s)

Resistant against trastuzumab or difficult to continue it due to intolerable side effect(s) when her-2 is positive

ECOG performance status 0-2

Life expectancy > 3 months

HLA-A*2402

Laboratory values as follows

2000/mm3<WBC<15000/mm3

Platelet count>100000/mm3

Bilirubin < 3.0mg/dl

Asparate transaminase < 150IU/L

Alanine transaminase < 150IU/L

Creatinine < 3.0mg/dl

Able and willing to give valid written informed consent

Exclusion Criteria:

Pregnancy(woman of childbearing potential:Refusal or inability to use effective means of contraception)

Breastfeeding

Active or uncontrolled infection

Concurrent treatment with steroids or immunosuppressing agent

Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks

Decision of unsuitableness by principal investigator or physician-in-charge

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259505